Medical Wire has recently been awarded a Record of Verification by Lloyds Register LRQA (as Notifying Body for European Medical Devices Directives) as official confirmation that its liquid medium Sigma Transwab® and Fecal Transwab® transport devices have been successfully validated for use on the COPAN WASP® Walk Away Specimen Processor in accordance with Cumitech 31A, Verification and Validation of Procedures in the Clinical Laboratory (American Society for Microbiology). Cumitech 31A complies with the United States CLIA (Clinical Laboratory Improvement Amendments) regulations, and providesmethods for the validation of alternative consumables for recognised test kits and platforms.

A large validation study was performed in France to assess the compatibility of MWE products on the WASP® Walk Away Specimen Processor (also called WASP®DT), by measuring Cumitech 31A’s key performance attributes of accuracy, precision, reportable range, comparing results with those achieved by the designated reference range. In the study 570 devices were tested on the WASP®, including 380 MWE Sigma Transwab® as the test devices, and 190 Copan™ e-swabs as the reference range. A further 60 devices (40 MWE and 20 Copan™) were tested manually.

Accuracy is the correct identification of test microorganisms, confirmed by comparing results obtained on the WASP® with those obtained by conventional manual methods. Precision is a measure of the system’s ability to produce the same results from identical inputs time after time. The reportable range is assessed when the system is challenged by differing concentrations of the same microorganism. The results for all tests are compared with those obtained for the system manufacturer’s own product as the reference range.

The validation study was conducted in France by a large regional laboratory serving a wide area, processing large numbers of specimens on a daily basis. It is not possible to ensure that only certain brands of swab are used across the population, so it is essential for this laboratory that any automated platform can handle all the various devices which may arrive in specimen reception. The reported study was designed to prove that the WASP® could successfully and efficiently process any specimens received in MWE Sigma Transwab® liquid medium swab devices.

The results of the study demonstrated complete concordance for all performance attributes between the MWE Sigma Transwab® liquid medium swab devices and the Copan™ e-swab devices.

The results of the study have previously presented at ECCMID 2017 in Vienna, and as an “Introducing Technology” presentation at the Institute of Biomedical Science Congress 2017 in Birmingham. The study and results have been fully assessed by Lloyds Register LRQA as Notifying Body for European Medical Devices Directives leading to the award of the Record of Verification.

Chatelain, N., 2017, Validation according to Cumitech 31A of the use of SIGMA TRANSWAB® and SIGMA TRANSWAB®PF with the WALK-AWAY SPECIMEN PROCESSOR (WASP®, COPAN), Abstract No 2395, ECCMID 2017, Vienna

Clark, R. B., M. A. Lewinski, M. J. Loeffelholz, and R. J. Tibbetts, 2009. Cumitech 31A, Verification and Validation of Procedures in the Clinical Microbiology Laboratory. Coordinating ed., S. E. Sharp. ASM Press, Washington, DC. (American Society for Microbiology)

Record of Verification Certificate, Lloyds Register LRQA Certificate Number 0939857/G

Note

COPAN®, ESWAB®, and WASP® (including WASP®DT) are registered trademarks of Copan Italia SPA.

Medical Wire & Equipment (MWE) is not affiliated with Copan Italia SPA.

Visit Medical Wire at MEDICA Dusseldorf 13-16 November (Booth 3aD10-2)